Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe

NCT02210039 | Completed Results

• 1 other identifier: 2013-P-001213
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being done to test the feasibility and tolerability of a SECM imaging probe in patients with Barrett's Esophagus (BE). Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM imaging will be performed continuously over a pre-determined length. Patients will later be asked for their feedback.

Conditions

Barrett's Esophagus

Keywords

SECM; Esophagus; Imaging

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Tolerability of the Procedure

  We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire.

  During the procedure

Study Arms (1)

SECM Probe Imaging

EXPERIMENTAL

SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.

Device: SECM Probe

Interventions

SECM Probe DEVICE

Imaging of the esophagus using SECM probe and system.

SECM Probe Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A previous diagnosis of Barrett's Esophagus
• Patients must be over the age of 18
• Patient must be able to give informed consent

You may not qualify if:

• Subjects with any history of intestinal strictures
• OR subjects with a history of prior GI surgery
• OR subjects with a history of intestinal Crohn's disease.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Guillermo Tearney, PI
• Organization: Massachusetts General Hospital

gtearney@partners.org

617-724-2979

Study Officials

• Guillermo Tearney, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pathology

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 6, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 3, 2019
• Results First Posted: October 23, 2018

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)